Professional, Quality Steward

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Technology Product & Platform Management

Technical Product Management

Scientific/Technology

New Brunswick, New Jersey, United States of America, Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

DePuy Synthes is recruiting for a Professional, Quality Steward located in New Brunswick, NJ or West Chester, PA or Palm Beach Gardens, FL or Warsaw, IN or Raynham, MA.

The Professional, Quality Steward is an established and productive individual contributor within the Cybersecurity function, accountable for embedding Secure by Design principles into the DePuy Synthes medical device and connected product portfolio. This role serves as the quality and security steward across the total product lifecycle — partnering with R&D, Product Management, Engineering, Regulatory Affairs, and Quality to ensure security requirements are defined early, designed in, verified through testing, and sustained through postmarket monitoring.

Working under moderate supervision, the analyst applies practical knowledge of product security, secure development practices, and medical device regulatory expectations to ensure products are safe, secure, compliant, and defensible to regulators and customers.

• Serve as the product security steward for assigned product lines, embedding Secure by Design requirements into the product development lifecycle from concept through end-of-support.
• Define and document security requirements, design inputs, and acceptance criteria in collaboration with product owners, systems engineers, and R&D teams during early design phases.
• Facilitate threat modeling and security architecture reviews for connected devices, embedded software, mobile applications, and supporting cloud services; ensure identified threats are mitigated and traceable to controls.
• Conduct and coordinate product security risk assessments aligned to AAMI TIR
  57 and ISO 14971, ensuring cybersecurity risk is integrated with overall product risk management files.
• Generate, validate, and maintain Software Bills of Materials (SBOMs) for products; monitor third-party and open-source components for known vulnerabilities and drive remediation planning.
• Support secure software development practices, including secure coding standards, static and dynamic analysis, dependency scanning, and integration of security gates into CI/CD pipelines.
• Coordinate penetration testing and security verification activities with internal teams and third-party assessors; triage findings, assess exploitability and patient safety impact, and track remediation to closure.
• Prepare and review cybersecurity documentation for regulatory submissions, aligned to FDA premarket cybersecurity guidance, EU MDR, and…